PE20210047A1 - Composicion inyectable - Google Patents
Composicion inyectableInfo
- Publication number
- PE20210047A1 PE20210047A1 PE2020001597A PE2020001597A PE20210047A1 PE 20210047 A1 PE20210047 A1 PE 20210047A1 PE 2020001597 A PE2020001597 A PE 2020001597A PE 2020001597 A PE2020001597 A PE 2020001597A PE 20210047 A1 PE20210047 A1 PE 20210047A1
- Authority
- PE
- Peru
- Prior art keywords
- composition
- letrozole
- active agent
- intramuscular
- milligrams
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/022—Filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
-
- A61L2103/05—
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Molecular Biology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Se refiere a una composicion de letrozol de liberacion mantenida estable para administracion por via intramuscular adecuada para formar un implante intramuscular in situ que comprende de 10 a 500 mg de letrozol y un polimero termoplastico biodegradable esteril de poli (acido lactico) (PLA), donde dicho PLA esta molido y/o tiene una distribucion masica del tamano de las particulas con como maximo 10 % superior a 300 micrometros, preferiblemente no superior a 250 micrometros, cuando se mide mediante tamizado analitico segun USP<786>; y donde la liberacion del agente activo desde el implante es entre 2 y 30 % del agente activo cada 28 dias, preferiblemente es entre 5 y 25 % del agente activo cada 28 dias; y/o donde la composicion libera de 0,1 a 2 miligramos de letrozol al dia, preferiblemente de 0,13 a 0,80 miligramos de letrozol al dia. Dicha composicion libera el farmaco con un comienzo inmediato de la accion y de manera continua entre 3 y 6 meses. La composicion intramuscular inyectable es de absorcion lenta y esteril. Tambien se refiere a un procedimiento para preparar dicha composicion y a un kit adecuado para la preparacion in situ.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18382413 | 2018-06-12 | ||
| PCT/EP2019/065318 WO2019238740A1 (en) | 2018-06-12 | 2019-06-12 | Injectable composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20210047A1 true PE20210047A1 (es) | 2021-01-08 |
Family
ID=62716017
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2020001597A PE20210047A1 (es) | 2018-06-12 | 2019-06-06 | Composicion inyectable |
Country Status (33)
| Country | Link |
|---|---|
| US (2) | US12226485B2 (es) |
| EP (1) | EP3746047B1 (es) |
| JP (1) | JP7420735B2 (es) |
| KR (1) | KR102902994B1 (es) |
| CN (1) | CN112004525B (es) |
| AU (1) | AU2019286572B2 (es) |
| BR (1) | BR112020020415A2 (es) |
| CL (1) | CL2020002844A1 (es) |
| CO (1) | CO2020012526A2 (es) |
| CY (1) | CY1124772T1 (es) |
| DK (1) | DK3746047T3 (es) |
| EA (1) | EA202092021A1 (es) |
| ES (1) | ES2900171T3 (es) |
| GE (2) | GEP20237501B (es) |
| HR (1) | HRP20211874T1 (es) |
| HU (1) | HUE057269T2 (es) |
| IL (1) | IL277802B2 (es) |
| LT (1) | LT3746047T (es) |
| MA (1) | MA52502B1 (es) |
| MD (1) | MD3746047T2 (es) |
| MX (1) | MX2020011732A (es) |
| MY (1) | MY203260A (es) |
| PE (1) | PE20210047A1 (es) |
| PH (1) | PH12020551740A1 (es) |
| PL (1) | PL3746047T3 (es) |
| PT (1) | PT3746047T (es) |
| RS (1) | RS62681B1 (es) |
| SG (1) | SG11202008744VA (es) |
| SI (1) | SI3746047T1 (es) |
| SM (1) | SMT202100678T1 (es) |
| UA (1) | UA127087C2 (es) |
| WO (1) | WO2019238740A1 (es) |
| ZA (1) | ZA202006113B (es) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4203917A4 (en) * | 2020-08-25 | 2024-10-09 | Merck Sharp & Dohme LLC | Injectable depot compositions for the delivery of antiviral agents |
| WO2025153747A1 (es) * | 2024-01-17 | 2025-07-24 | Laboratorios Farmacéuticos Rovi, S.A. | Composiciones y esquemas de dosificación de inhibidores de aromatasa mejorados |
Family Cites Families (49)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US3773919A (en) | 1969-10-23 | 1973-11-20 | Du Pont | Polylactide-drug mixtures |
| BE758156R (fr) | 1970-05-13 | 1971-04-28 | Ethicon Inc | Element de suture absorbable et sa |
| US4389330A (en) | 1980-10-06 | 1983-06-21 | Stolle Research And Development Corporation | Microencapsulation process |
| US4530840A (en) | 1982-07-29 | 1985-07-23 | The Stolle Research And Development Corporation | Injectable, long-acting microparticle formulation for the delivery of anti-inflammatory agents |
| US4523591A (en) | 1982-10-22 | 1985-06-18 | Kaplan Donald S | Polymers for injection molding of absorbable surgical devices |
| JP2670680B2 (ja) * | 1988-02-24 | 1997-10-29 | 株式会社ビーエムジー | 生理活性物質含有ポリ乳酸系微小球およびその製造法 |
| US4938763B1 (en) | 1988-10-03 | 1995-07-04 | Atrix Lab Inc | Biodegradable in-situ forming implants and method of producing the same |
| US5620700A (en) | 1990-10-30 | 1997-04-15 | Alza Corporation | Injectable drug delivery system and method |
| SG47445A1 (en) | 1993-11-19 | 1998-04-17 | Janssen Pharmaceutica Nv | Microencapsulated 3-piperidinyl-substituted1 1 2-benzisoxazoles and 1 2-benzisothiazoles |
| WO1998027962A2 (en) | 1996-12-20 | 1998-07-02 | Alza Corporation | Injectable depot gel composition and method of preparing the composition |
| KR100289471B1 (ko) | 1998-01-19 | 2001-09-17 | 김충섭 | 휀타닐계마취제의이식형서방성제제 |
| US6143314A (en) | 1998-10-28 | 2000-11-07 | Atrix Laboratories, Inc. | Controlled release liquid delivery compositions with low initial drug burst |
| US6565874B1 (en) | 1998-10-28 | 2003-05-20 | Atrix Laboratories | Polymeric delivery formulations of leuprolide with improved efficacy |
| US6461631B1 (en) | 1999-11-16 | 2002-10-08 | Atrix Laboratories, Inc. | Biodegradable polymer composition |
| DK1248596T3 (da) | 2000-01-11 | 2007-07-02 | Bertex Pharma Gmbh | Implantater, partikler |
| US6604561B2 (en) | 2000-02-11 | 2003-08-12 | Medical Instill Technologies, Inc. | Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial |
| AU3838401A (en) | 2000-02-17 | 2001-08-27 | 3M Innovative Properties Co | Delivery systems using preformed biodegradable polymer compositions and methods |
| WO2002038185A2 (en) | 2000-11-13 | 2002-05-16 | Atrix Laboratories, Inc. | Injectable sustained release delivery system with loperamide |
| WO2004064752A2 (en) | 2003-01-22 | 2004-08-05 | Alkermes Controlled Therapeutics, Inc. | Method of preparing sustained release microparticles |
| JP2007525429A (ja) | 2003-03-11 | 2007-09-06 | キューエルティー ユーエスエー，インコーポレイテッド． | 細胞スケジュール依存性抗癌剤のための処方 |
| DK1660039T3 (en) | 2003-07-18 | 2017-01-16 | Oakwood Laboratories L L C | PREVENTION OF REDUCTION OF THE POLYMER MOLECULE WEIGHT, THE PREPARATION OF PURPOSES AND GELING IN POLYMER COMPOSITIONS |
| US8221778B2 (en) | 2005-01-12 | 2012-07-17 | The Trustees Of The University Of Pennsylvania | Drug-containing implants and methods of use thereof |
| GB0420016D0 (en) | 2004-09-09 | 2004-10-13 | Leuven K U Res & Dev | Controlled release oral delivery system |
| MX2007003789A (es) | 2004-10-04 | 2007-07-20 | Qlt Usa Inc | Suministro ocular de formulaciones polimericas para suministro. |
| DE102005031868A1 (de) | 2005-07-04 | 2007-01-18 | Biotronik Vi Patent Ag | Arzneimitteldepot zur parenteralen, insbesondere intravaskulären Arzneimittelfreisetzung |
| GB0517673D0 (en) | 2005-08-31 | 2005-10-05 | Astrazeneca Ab | Formulation |
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| UA95088C2 (ru) * | 2005-10-21 | 2011-07-11 | Панасеа Биотек Лтд. | Композиция, которая содержит наночастички связанные с биосовместимым полимером противоракового агента и снижает аллопецию при химиотерапии, способ ее получения |
| US20100098735A1 (en) | 2006-10-05 | 2010-04-22 | Rajesh Jain | Injectable depot compositions and its process of preparation |
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| FR2908775B1 (fr) | 2006-11-17 | 2012-08-31 | Biomatlante | Hydrogel et ses applications biomedicales |
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| HUE030789T2 (en) | 2007-05-18 | 2017-06-28 | Durect Corp | Improved depot formulation |
| WO2008153611A2 (en) | 2007-05-25 | 2008-12-18 | Qlt Usa, Inc. | Sustained delivery formulations of risperidone compounds |
| AR070033A1 (es) * | 2007-11-06 | 2010-03-10 | Panacea Biotec Ltd | Composiciones inyectables, sus procesos y usos |
| US8629172B2 (en) | 2008-04-18 | 2014-01-14 | Warsaw Orthopedic, Inc. | Methods and compositions for treating post-operative pain comprising clonidine |
| US20100144687A1 (en) | 2008-12-05 | 2010-06-10 | Glaser Rebecca L | Pharmaceutical compositions containing testosterone and an aromatase inhibitor |
| US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
| US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
| ES2390439B1 (es) * | 2012-08-03 | 2013-09-27 | Laboratorios Farmacéuticos Rovi, S.A. | Composición inyectable |
| US10335366B2 (en) | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
| LT2394663T (lt) | 2010-05-31 | 2022-02-10 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozicijos, skirtos įšvirkščiamiems in situ biologiškai skaidiems implantams |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| HUE029895T2 (en) | 2010-05-31 | 2017-04-28 | Farm Rovi Lab Sa | Antipsychotic injectable depot composition |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| WO2012074883A1 (en) | 2010-11-24 | 2012-06-07 | Durect Corporation | Biodegradable drug delivery composition |
| DK2529756T3 (da) | 2011-05-31 | 2021-08-02 | Farm Rovi Lab Sa | Risperidon- og/eller paliperidon-implantatformulering |
| PL2529757T3 (pl) | 2011-05-31 | 2014-04-30 | Farm Rovi Lab Sa | Formulacja implantu zawierającego paliperydon |
| CN102512399B (zh) * | 2011-12-31 | 2013-05-01 | 湖南赛沃药业股份有限公司 | 一种长效纳曲酮植入剂及其制备方法 |
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2019
- 2019-06-06 PE PE2020001597A patent/PE20210047A1/es unknown
- 2019-06-12 EP EP19733972.4A patent/EP3746047B1/en active Active
- 2019-06-12 MY MYPI2020005177A patent/MY203260A/en unknown
- 2019-06-12 JP JP2020557943A patent/JP7420735B2/ja active Active
- 2019-06-12 WO PCT/EP2019/065318 patent/WO2019238740A1/en not_active Ceased
- 2019-06-12 DK DK19733972.4T patent/DK3746047T3/da active
- 2019-06-12 HR HRP20211874TT patent/HRP20211874T1/hr unknown
- 2019-06-12 KR KR1020207028732A patent/KR102902994B1/ko active Active
- 2019-06-12 GE GEAP201915469A patent/GEP20237501B/en unknown
- 2019-06-12 MA MA52502A patent/MA52502B1/fr unknown
- 2019-06-12 SI SI201930141T patent/SI3746047T1/sl unknown
- 2019-06-12 RS RS20211463A patent/RS62681B1/sr unknown
- 2019-06-12 MX MX2020011732A patent/MX2020011732A/es unknown
- 2019-06-12 CN CN201980027406.XA patent/CN112004525B/zh active Active
- 2019-06-12 GE GEAP202215469A patent/GEAP202215469A/en unknown
- 2019-06-12 LT LTEPPCT/EP2019/065318T patent/LT3746047T/lt unknown
- 2019-06-12 EA EA202092021A patent/EA202092021A1/ru unknown
- 2019-06-12 SM SM20210678T patent/SMT202100678T1/it unknown
- 2019-06-12 PT PT197339724T patent/PT3746047T/pt unknown
- 2019-06-12 AU AU2019286572A patent/AU2019286572B2/en active Active
- 2019-06-12 PL PL19733972T patent/PL3746047T3/pl unknown
- 2019-06-12 SG SG11202008744VA patent/SG11202008744VA/en unknown
- 2019-06-12 HU HUE19733972A patent/HUE057269T2/hu unknown
- 2019-06-12 BR BR112020020415-3A patent/BR112020020415A2/pt unknown
- 2019-06-12 ES ES19733972T patent/ES2900171T3/es active Active
- 2019-06-12 IL IL277802A patent/IL277802B2/en unknown
- 2019-06-12 UA UAA202005782A patent/UA127087C2/uk unknown
- 2019-06-12 MD MDE20201233T patent/MD3746047T2/ro unknown
-
2020
- 2020-10-02 ZA ZA2020/06113A patent/ZA202006113B/en unknown
- 2020-10-07 CO CONC2020/0012526A patent/CO2020012526A2/es unknown
- 2020-10-20 PH PH12020551740A patent/PH12020551740A1/en unknown
- 2020-11-03 CL CL2020002844A patent/CL2020002844A1/es unknown
- 2020-11-23 US US17/101,585 patent/US12226485B2/en active Active
-
2021
- 2021-11-29 CY CY20211101043T patent/CY1124772T1/el unknown
-
2025
- 2025-01-10 US US19/016,558 patent/US20250144218A1/en active Pending
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